Field of the Invention
The present invention relates to an endotoxin detection system on the basis of laser particle size detection and a corresponding detection method thereof, which fall within the field of detection of bacterial endotoxin.
Description of Related Art
Bacterial endotoxin is a lipopolysaccharide widely present in the nature, is also known as liposome and is a constituent in the external cell wall of Gram negative bacteria. After entering the blood circulation in human body, the substance may cause fever, that is, the commonly known pyrogenic reaction. Since the substance may cause serious adverse effects to human, its presence in pharmaceutical injections needs to be strictly controlled.
At present, the laser particle size detector has not found use in detection of endotoxin. As a high-sensitivity detector, the Malvern Nano ZS ZEW3600 laser particle size analyzer is shown to detect the particles of endotoxin in a solution only at a concentration above 10 EU/ml, which fails to satisfy the requirements for endotoxin detection in injections. The particle size analysis by the laser particle size detector is performed with multi-point scattered light signals from more than two points based on differences in scattered light signals from the particles at different angles. However, the laser particle size detector is still not applicable to detection of particle concentration.
The detection of bacterial endotoxin may be either qualitative or quantitative. A conventional detection method uses rabbit, where a test sample is intravenously injected into rabbit, and changes in body temperature are observed for a specified period of time. The method may be subjected to interference from many factors, poor sensitivity, and especially potential occurrence of false negative results for antipyretic drugs or heat-clearing and detoxicating injections. In the pharmacopoeia of People's Republic of China, tachypleus amebocyte lysate (TAL) test is used for detection of endotoxin; however, the method has the disadvantages of long preparation time, extended detection time, and high cost, and rapid, continuous, and on-line detection cannot be realized therewith.